Operational policy for the approval of food establishments undertaken by the Food Standards Agency

# UK Meat Establishment Approvals

Operational Policy for Approvals Undertaken by the FSA

## Table of contents

| Section | Page | |------------------------------------------------------------------------|------| | UK Meat Establishment Approvals | 2 | | Background | 3 | | Governance arrangements | 5 | | Establishments requiring approval | 6 | | Responsibilities of Food Business Operators | 9 | | Approval requirements | 10 | | Approval number / identification mark | 21 | | Review of meat establishments approval with the view to withdraw or suspend | 23 | | Changes to an approval | 25 | | Annex A - Type of Establishments that require approval by FSA | 31 | | Annex B - Exemption Criteria | 34 | | Annex C - Exemption criteria – Flow diagram | 37 | | Annex D - Approval process – Decision flow diagram | 38 | | Annex E - Review of approval - Decision flow chart | 39 | | Annex F - Change of FBO | 40 | | Annex G - Relevant offences | 41 | | Glossary | 42 | Background

1. This document sets out the Food Standards Agency’s (FSA) implementation of the requirements of Regulation 2017/625, for approving meat establishments under Regulation 853/2004 in England, Wales and Northern Ireland (NI). Since April 2015 Food Standards Scotland have been responsible for the approval of slaughterhouses, cutting plants and game handling establishments in Scotland.

2. The Food Hygiene Regulations (“Hygiene regulations”) have applied in all Member States from 1 January 2006. These regulations are:

- **Regulation 178/2002** – General Food Law Regulation: This regulation provides a framework for food and feed law and applies to food and feed business operators. It applies to all stages of production, processing and distribution of food and feed, but does not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. The principal aim of the regulation is to protect public health and consumers’ interests in relation to food.

- **Regulation 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and protection products:** This includes procedures to be followed concerning the approval of establishments as required under Regulation 853/2004.

- **Regulation 852/2004** on the hygiene of foodstuffs: This sets out general hygiene rules that apply to all registered and approved food businesses including structural requirements and the implementation of procedures based on hazard analysis and critical control point (HACCP) principles. The regulation sets out objectives for “good hygiene practices” to protect consumers.

- **Regulation 853/2004** laying down specific hygiene rules for food of animal origin: This includes requirements for businesses producing Products of Animal Origin (POAO) that apply in addition to those set out in Regulation 852/2004, including the requirement for establishments to be approved.

3. As the Competent Authority (CA) the FSA must establish procedures in accordance with the provisions of Article 148 of Regulation 2017/625, for approving meat establishments under Regulation 853/2004.

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1. Regulation 178/2002 laying down the general principles and requirements of food law and laying down procedures in matters of food safety

2. Regulation 852/2004 on the hygiene of foodstuffs

3. Regulation 853/2004 laying down specific hygiene rules for food of animal origin

4. Regulation 853/2004 requires that food business establishments handling food of animal origin which falls under the categories for which Annex III lays down requirements must, with some exceptions, be approved by the CA.

5. For the purposes of these regulations, in accordance with Article 2 and 3 of Regulation 178/2002 the following definitions apply:

- ‘food business’ means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food.

- ‘food business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control.

- ‘food law’ means the laws, regulations and administrative provisions governing food in general, and food safety in particular it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals.

- ‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.

06. Compliance with relevant requirements of Regulation 853/2004 is required in addition to compliance with Regulation 852/2004. However, registration under Article 6(2) of Regulation 852/2004 is not required for establishments subject to approval.

07. Slaughterhouses, Cutting Plants and Game Handling Establishments require veterinary control and must be approved by the FSA in England, Wales and Northern Ireland.

08. Any co-located Cold store, Re-wrapping Establishment, Minced meat, Meat Preparations, Mechanically Separated Meat Establishment or Processing Plant are also approved by the FSA. When stand-alone, these establishments are approved by the relevant Local Authority (LA) or District Council (DC) in NI.

09. Food Business Operators can find further guidance on food hygiene and other regulations for the UK Meat Industry in the Meat Industry Guide.

10. The Meat Industry Guide has been produced by meat industry representatives for use by UK food businesses involved in the slaughter, cutting and processing of fresh meat, and especially those subject to veterinary control by the FSA in England and Wales; or the Department of Agriculture, Environment and Rural Affairs (DAERA) in Northern Ireland. It should be particularly helpful for prospective food businesses seeking an approval to start such operations. It is also an important reference for enforcement officials.

11. The Meat Industry Guide provides non-binding advice on the legal requirements of the Food Hygiene Regulations and should be read in conjunction with the legislation itself (quoted in each chapter) with which businesses have to comply. The text should Governance arrangements

12. Responsibility for the policy on approvals is held by the Operations Assurance Division in England and Wales and by the Policy and Delivery Division in Northern Ireland. Policy oversight will be carried out at the appropriate level depending on the sensitivity or impact of the issue, with the FSA’s Board having clear sight of the operation of the approvals system, with the strategic involvement of the FSA’s Chief Executive or the Board, if and when required.

13. Approval assessments and recommendations in England and Wales are provided by veterinary officials in the FSA field management structure. Decisions on approval are made by a Senior Civil Servant. In the absence of a suitable senior civil servant decisions may be delegated to an authorised official within the Operations Assurance Division. Decisions on approvals in Northern Ireland are made by the Head of Operations.

14. The official responsible for decisions may convene a panel to assist in their deliberations. The panel will consist of, or a representative of, the Head of Operations Assurance, the Head of Field Operations, the Operations Head Veterinarian, FSA Legal, and the veterinary official making the recommendation. The panel will typically be convened in cases which may result in a refusal to grant approval or a withdrawal of approval. A similar arrangement is in place for Northern Ireland.

15. There is a separation of functions between the officials involved in assessments, recommendations and decisions on approvals and the officials responsible for conducting the audits of approved meat establishments.

16. The authorised officials work in collaboration and base their decisions upon the recommendation and evidence presented by the veterinary official who conducted the approval assessment along with other relevant information available such as the outcomes of recent official controls. Establishments requiring approval

Type of establishments

17. The meat establishments listed below are subject to Regulations 852/2004 and 853/2004 and must be approved by the FSA, in order to operate, unless they meet the exemption criteria in Regulation 853/2004: a. Slaughterhouses b. On Farm Slaughter facilities c. Game Handling Establishments d. Cutting Plants e. Wholesale Meat Markets

18. In England, Wales and Northern Ireland, where establishments are co-located with an approved Slaughterhouse, Cutting Plant or Game Handling Establishment, then the following associated meat activities are also approved by the FSA. In the case of such establishments operating in a stand-alone capacity, they are approved by Local Authorities: a. Minced Meat Establishments b. Meat Preparations Establishments c. Mechanically Separated Meat Establishments d. Processing Plants (Meat products, Rendered animal fats & greaves, Treated stomach, bladders & intestines, Gelatine and Collagen) e. Cold Stores f. Re-wrapping and Re-packaging Establishments

19. In Northern Ireland, District Councils are responsible for official controls and the recommendation of approval to the FSA of meat product and edible co-product activities in co-located establishments.

20. Where an approved meat establishment in England and Wales is also handling other products of animal origin (POAO) the FSA, in liaison and agreement with the relevant LA, may approve all operations requiring approval under Regulation 853/2004 undertake official controls. Such approvals which remove the need for dual enforcement by the FSA and LA will be determined on a case by case basis.

21. Where the removal of dual enforcement is not practical then in order to avoid the allocation of dual approval numbers to the co-located establishment by the FSA and LA, the FSA should issue the approval to the establishment as a whole. The approval covering letter should explain the areas of responsibility and a list of all activities in the establishment should be included in the approval letter. Activities that fall within Regulation 852/2004 only, such as butcher’s shops and where the establishment is also handling non-POAOs or the parts of the premises where these operations are carried out will be under the control of the LA and are not allocated an FSA approval number.

22. There is no requirement for veterinary control of meat Cold stores or Re-wrapping/Re-packaging establishments, but cold stores still require approval in so far as they are used for activities for which Annex III of Regulation 853/2004 lays down requirements. LAs will be responsible for approving cold stores, unless they are co-located with a Slaughterhouse, Cutting Plant or Game Handling Establishment.

23. If a cold store intends to undertake re-wrapping or re-packaging, then it must be additionally approved as a re-wrapping and/or re-packaging establishment. In order to ensure traceability, the FBOs should not place on the market re-wrapped or re-packaged POAO unless the identification mark of the re-wrapping/re-packaging establishment is applied.

24. Where an approved establishment also undertakes cold storage of brought – in products of animal origin, the approval document should reflect the cold storage activity in addition to all other activities undertaken within the establishment.

25. Establishments that cut raw meat exclusively for the manufacture of meat products, minced meat, meat preparations or mechanically separated meat, require approval in respect of their manufacturing activities. They also need to comply with the requirements of Annex III of Regulation 853/2004, including those relating to cutting plants. However, because they do not place the meat they cut on the market as fresh meat they will not require approval as a ‘cutting plant’ and therefore do not require veterinary control.

26. The table at Annex A shows the establishments in column one which must be approved under Regulation 853/2004, to carry out the operations in column two.

27. Regulation 853/2004 Annex I provides definitions of the terms applicable in fresh and processed meat establishments.

Exemptions from approval

28. Regulation 853/2004 provides certain exemptions from approval. In terms of establishments for which the FSA may need to consider for approval the exemptions fall into the following basic categories: a. Retail Establishments b. Poultry Slaughter and Cutting on Farm c. Slaughter for Private Domestic Consumption d. Wild Game

29. Full details of these exemptions are provided in Annex B, an extract from the Meat Industry Guide. For retail establishments, the flow diagram in Annex C can be used to determine if the operator qualifies for exemption from the need to be approved:

30. In addition to the exemptions stated above there are other situations where approval may not be required but will still require registration or authorisation with the relevant LA or DC, these are detailed as follows:

Collection centres and tanneries

1. Collection centres and Tanneries may supply raw material for the production of gelatine and collagen intended for human consumption. They are not subject to the requirements of Regulation 852/2004, nor are they subject to approval under Regulation 853/2004.
2. They are, however, specifically authorised by the relevant body on behalf of the Agency in NI in accordance with Regulation 853/2004 Annex III Section XIV (Gelatine) Chapter 1(5) and Section XV (Collagen) Chapter 1(5) and must also meet the other requirements of Annex III, Section XIV (Gelatine) and Section XV (Collagen) of Regulation 853/2004.

Farmers markets

3. Establishments producing POAO for supply to the final consumer at farmers’ markets, or at other markets supplying the final consumer, are regarded as supplying the final consumer directly and on this basis the market can be treated as an extension of the producer’s establishment. Therefore, producers supplying POAO are not subject to approval under Regulation 853/2004, subject to the following conditions: a. There is no change of control of the POAO (e.g. farmer A cannot cut meat and supply it to farmer B to sell at the market); and b. The operation does not involve supply other than to the final consumer. Suppliers to shops or restaurants would render the premises subject to approval unless they meet the exemption criteria in Regulation 853/2004.

4. Producers supplying POAO at their own farmers’ market stall or other markets supplying the final consumer should be regarded as if they were supplying the final consumer directly, on the basis that the market can be regarded as an extension of the producer’s establishment. Furthermore, such sales should be treated as other sales to the final consumer and are not limited to the “localised” sale criterion.

Production of composite products

5. Production of food containing both products of plant origin and processed products of animal origin, known as ‘Composite Products’, is subject to Article 1(2) of Regulation 853/2004 which states that: “Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation”.

6. Therefore, a food business operator who: a. assembles processed products of animal origin with products of plant origin does not need approval, even if that product is then further processed i.e. Regulation 852/2004 would be appropriate to that operations b. further processing of a processed product of animal origin prior to combining it with food of plant origin would need approval for that processing. The subsequent assembling of the processed product of animal origin with product of plant origin does not need approval, even if that (combined) product is then further processed i.e. registration would be appropriate to that operation c. assembles food of plant origin with unprocessed food of animal origin that is further processed together would need approval Note - The addition of a product of plant origin to a processed product of animal origin does not automatically mean that the resulting food would be a composite product. For example, cheese to which herbs are added or sausages to which garlic or soya are added must be performed under Regulation 853/2004.

7. Annex III of the EC Guidance document on the implementation of the provision of Regulation 852/2004 gives an overview of the scope of this Regulation. However, the list is not exhaustive and therefore purely indicative.

Responsibilities of Food Business Operators

31. Regulation No 2017/625 obliges competent authorities to establish procedures for food business operators to follow when applying for approval under Regulation (EC) No 853/2004 to which requirements within Regulation 852/2004 also applies.

32. Article 6(2) of Regulation 852/2004 requires food business operators (FBO) to notify the CA “of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment” and Article 6(3) of the same regulation states that “food business operators shall ensure that establishments are approved by the CA, following at least one on-site visit, when approval is required.”

33. This places the legal onus on the FBO to make sure that establishments which are subject to approval are approved before they commence trading.

34. An “establishment” is any unit of a food business and denotes both premises and the manner in which those premises are being used by the food business operator. The approval of an “establishment” applies to both the “premises” and the business operating at the premises and, therefore, it is the entirety of the premises, the FBO and activity that must be approved.

35. To gain and retain approval, the FBO must meet all the requirements of the Food Hygiene Regulations and other relevant legislation as required for the type of establishment. These particularly include (but this is not intended as a definitive list):

- **Regulation 2073/2005** – Microbiological Criteria for Foodstuffs: Microbiological criteria are set for products of animal origin including carcases of cattle, sheep, pigs, goats and horses, broiler chickens and turkeys, and for minced meat, meat products, and meat preparations.

- **Regulation No 2074/2005** laying down implementing measures for certain products under 853/2004 and for the organisation of official controls under 854/2004 and 2017/625, derogating from 852/2004 and amends 853/2004:

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5 [Regulation 2073/2005 on microbiological criteria for foodstuffs](#) 6 [Regulation 2074/2005 laying down implementing measures for certain products](#) This provides the implementing measures for certain food business obligations and food products included in the hygiene package.

- **Regulation 1099/2009** “The Protection of Animals at the time of Killing” (PATOK) and the Welfare of Animals at the Time of Killing Regulations (WATOK) which provide the welfare requirements for animals in slaughterhouses.

The Food Hygiene Regulations: give effect to the provisions of the Food Hygiene Regulations and the implementing and transitional measures (including the EU Microbiological Criteria Regulation).

- **Regulation 1069/2009** – Animal By-Product Controls: Laying down health rules concerning animal by-products not intended for human consumption.

36. Article 6(2) of Regulation 852/2004 also requires the FBO to “ensure that the CA always has up-to-date information on establishments, including by notifying any significant change in activities and any closure of an existing establishment” (refer to Changes to an Approval section). Not complying with this requirement is an offence under the domestic hygiene regulations.

37. In the context of this article, a change of FBO constitutes a closure of an existing establishment’s approval.

**Approval requirements**

**Application for approval**

38. Following an enquiry from a prospective FBO the FSA will provide the applicant with an application form. Application forms are also available to download from the FSA website.

39. A FBO can only make an application for approval for an establishment under their control and only for processes and/or activities that they intend to carry out.

40. The applicant must provide details of: a. the premises for which approval is requested; b. the activities and species for which approval is sought; and c. the identity of the FBO including relevant contact and address details.

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7 Regulation 1099/2009 on the protection of animals at the time of killing 8 Welfare of Animals at the Time of Killing (England) Regulations 2015 9 Food Safety and Hygiene (England) Regulations 2013 10 Regulation 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption 11 Applying for approval of a meat establishment 12 This could include a reference to any Day Book or enforcement programme entries made that evidence advice/guidance given. 41. Article 3 of Regulation 178/2002 states “food business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control”.

- A natural person is a human being, (as opposed to an artificial, legal or juristic person, i.e., an organization that the law treats for some purposes as if it were a person distinct from its members or owner).

- A legal person has a legal name and has rights, protections, privileges, responsibilities, and liabilities under law, just as natural persons (humans) do. Legal personality allows one or more natural persons to act as a single entity (a composite person - considered under law separately from its individual members or shareholders) for legal purposes.

42. The legislation allows for natural and legal persons to be FBOs therefore the CA requires the applicant to identify themselves (including the name of officers, address and proof of status) as either a: a. Sole trader or partnership (natural person/s) who is required to be compliant with food law. b. Incorporated and registered company (legal person) which is required to be compliant with food law (even though the actions of the company are carried out by human hands). c. Other business types such as cooperatives, registered charities and other specialised types of organisation will have to establish the natural or legal person who will have control and responsibility for the operation of the food business.

43. Applications for approval are required for new builds / start-up food businesses and are also required in the following circumstances: a. Registered establishments under Regulation 852/2004 applying to undertake activities that are approved by the FSA. b. Establishments approved by the LA or DC applying to undertake activities that are approved by the FSA (i.e. Slaughterhouses, Cutting plants or Game Handling Establishments) to become co-located (refer to Type of establishments section). c. Establishments already approved by the FSA wishing to undertake additional approvable activities.

Advisory visits

44. The FSA may offer an advisory visit to those food businesses that have applied for approval prior to an approval visit. The aim of an advisory visit is to help FBOs identify any problems in the areas of structure and maintenance and food safety management to avoid any potential difficulties when the establishment is assessed for approval. The FSA will apply a fully recoverable charge for all advisory visits.

45. FBOs must be aware that there is a difference between an advisory visit and an approval visit. The FSA reaffirms that the FBO will not be able to undertake activities, that are approved by the FSA, until an approval visit has been carried out and a decision following such visit has been formally conveyed to the FBO. Note - The FBO will not be able to undertake activities that are approved by the Agency, until approval or conditional approval is granted.

Past compliance history

49. There is no obligation for a FSA to grant an approval. An approval can only be granted where the FBO has demonstrated compliance with the relevant requirements of food law which also includes animal health and welfare requirements.

50. The FSA may also take into account past compliance with the requirements of food law, animal health and animal welfare rules as a relevant factor and may be used as an indicator of likely future compliance with the requirements of food law. This will include past compliance by and the applicant and any relevant person.

51. In assessing compliance with the requirements of food law, the FSA will use the following criteria, as relevant

- The potential consequences for the objective of achieving a high level of consumer protection with regards to food safety and food hygiene
- Potential consequences for legitimate business
- The culpability of the applicant and whether any contraventions were the result of deliberate acts
- Whether any prior warnings, advice and/or guidance have been provided and the response to this(^{12})
- Whether the applicant record demonstrates repeated failures of infrastructure, procedures or management controls
- Whether the applicant has been reticent in explaining circumstances, has been uncooperative or abusive to CA staff and those from its contractual services providers, e.g. OVs provided by Eville & Jones or DAERA.
- Whether the applicant has previously had an application for approval refused or conditional approval not extended, full approval refused, or either conditional or full approval withdrawn, and the circumstances in each case
- Whether the applicant has been convicted of a relevant offence
- Whether there has been a failure to disclose any relevant offences
- Repeated significant and/or numerous non-compliances continuing without regard to warnings or advice

(^{12}) This could include a reference to any Day Book or enforcement programme entries made that evidence advice/guidance given. 52. Applicants are also required to disclose in their application any relevant conviction against themselves or other relevant persons. ‘Relevant person’ is the person applying for the approval and any person connected to the applicant and includes:

**For companies**

- the company itself
- the officers of the company (a director, manager, secretary or other similar officer)
- other companies, when the officers of the company were officers of that other company when they were convicted

**For partnerships and limited liability partnerships (LLP)**

- the individual partners
- the individual partners in the limited liability partnership
- partners within a partnership or limited liability partnership that have either been convicted of a relevant offence themselves, or who held a position as a partner, or partner in another LLP or corporate body when it was convicted of a relevant offence

**For individuals**

- the individual
- companies for which the individual is an officer (a director, manager, secretary or other similar officer)
- partnerships and limited liability partnerships that the individual is a partner of

53. Offences that are relevant are set out in Annex I. The CA must take into account the terms of the Rehabilitation of Offenders Act 1974 and the applicant does not need to disclose ‘spent convictions’ covered by that Act. The Act applies only where an individual has been convicted of an offence. However, where the person convicted is a corporate body, the CA should have regard to whether the conviction would have been spent if it had been committed by an individual and should normally treat the corporate body in the same way.

54. If during checks the CA discovers a relevant conviction against the applicant which has not been disclosed, the CAs may refuse the application or the CA may contact the applicant which will delay the decision to approve or otherwise.

55. Refusal of approval would normally be appropriate for offences that demonstrate a deliberate disregard for the requirements of food law, animal health and animal welfare rules, for example where there are repeated convictions, [or deliberately making false or misleading statements].

56. If it thinks it right to do so, the CA may still decide to grant conditional approval or full approval even though an applicant has demonstrated a poor record of compliance with regulatory requirements such as being convicted of a relevant offence.

Approval procedures

57. Article 148 of Regulation 2017/625 provides that competent authorities: a. shall establish procedures for food business operators to follow when applying for the approval of their establishment b. on receipt of an application for approval, shall make an on-site visit c. shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it complies with the relevant requirements of food law

58. Following an on-site visit: a. the FSA may grant conditional approval if the establishment meets all the infrastructure and equipment requirements. The food business may not have a fully developed and documented HACCP based procedures but the planned method of operation must not constitute a risk to public health and there must be adequate provision to control any such risks that have been identified. This is particularly so for high risk food items such as ready to eat meat products and minced meat/burger intended to be eaten less than thoroughly cooked. The FBOs food safety management system needs to be available to the FSA. b. full approval shall only be granted where it appears from a new official control visit, which must be carried out within three months of conditional approval, that the establishment meets all structural and equipment requirements and other relevant requirements of food law, including the need to implement an effective food safety management system based on HACCP principles c. if clear progress has been made but the establishment and food business still does not meet all of the relevant requirements, conditional approval may be extended, but must not exceed a total of six months. In such cases the establishment must still meet all the infrastructure and equipment requirements d. the FSA shall grant full approval if the establishment and food business complies with all the relevant requirements of food law (infrastructure, equipment and operational requirements) and the establishment has been observed in operation

59. Where the above requirements are not met and approval cannot be granted the FSA will refuse or discontinue approval.

60. Conditional approval will be refused if there are structural or equipment deficiencies at the initial approval visit.

61. Full approval subsequent to conditional approval will be refused: a. if, within the three months’ conditional approval, insufficient progress has been made to meet the requirements in full and, in the judgement of the FSA, there is insufficient evidence to demonstrate that the necessary work will be completed if a further period of conditional approval is granted, conditional approval will cease to have effect b. if, at the end of the six months period there is insufficient compliance with structural, equipment or operational requirements and other relevant requirements of food law, including the implementation of an effective food safety management system based on HACCP principles

62. Approval will be discontinued if, following conditional approval and before consideration can be given to recommend full approval or prolong conditional approval the establishment ceases operations or a visit cannot be undertaken caused by the relevant activities not being in operation. In such cases conditional approval will cease to have effect.

63. The procedures detailed above are also shown in a flow diagram at Annex D.

64. In between each period of conditional/extended conditional approval the FSA may conduct unannounced visits to check the food business compliance with operational hygiene requirements. Evidence of non-compliance with these requirements may result in appropriate enforcement action and may be used as evidence in the final decision whether to grant or to refuse to grant full approval.

Approval visits & assessments

65. On-site visits undertaken with a view to the approval of premises will be undertaken by a Veterinary Official. The FSA will make an appointment with the FBO or their representative. Following an approval visit the Agency will make an assessment of the compliance with the approval requirements for the premises and FBO controls.

66. Following conditional approval, measures must be taken by the FBO within the conditional approval period to remedy any operational or food safety management system deficiencies on a permanent basis. The initial conditional approval period of up to three months may only be extended for a further period if progress is made to remedy any deficiencies during the initial period and if, in the judgement of the Agency, there is evidence that the necessary work will be completed if a further period of conditional approval is granted. The total period of conditional approval cannot exceed six months; at the end of the conditional approval period, all aspects of compliance will be reassessed.

67. Although conditional approval may last up to three months or if extended up to a maximum of six months, assessment for full approval may be undertaken at any time after conditional approval has been granted.

68. Before full approval can be recommended, the food business must be observed in operation to verify that it meets all the requirements of food law, and other relevant legislation as required for the type of approval.

69. Where the slaughter of all species requiring approval cannot be reasonably seen on an approval visit professional judgement can be used. When the veterinary official reaches a point where they are satisfied with infrastructure, equipment and the FBO controls they should recommend approval, even if every species has not been observed in operation.

70. In the case of establishments operating a seasonal pattern, conditional approval may be split into two or more periods as long as the combined period does not exceed six

13 A person who is given the authority to stand in the place of the FBO months. Wherever possible the FSA will aim to conclude the approval process within one season even if it means that conditional approval will last for less than the allowed three or six months. However, where this is not practicable conditional approval may be split.

71. In these cases the veterinary official undertaking the assessment must satisfy themselves that:

**Seasonal establishments**

- it is practical to split the approval across one or more seasons and any potential risk to public health is managed;
- measures will be taken by the FBO within the expected conditional approval period to remedy any operational or food safety management system deficiencies on a permanent basis; and
- full approval is achievable within three years.

72. Depending on the type of application for approval there are several specific requirements applicable when an approval visit/assessment is undertaken. These are as follows:

**Food businesses transferring from LA control**

1. Until conditionally approved by the FSA, responsibility for enforcement action remains with the LA. When assessing for approval the FSA, where possible in consultation with the relevant LA will consider whether any enforcement action for the protection of public health is needed and communicate this to the relevant LA.

2. With the industrial nature of the processes and likelihood of daily damage to structure and equipment, it would be unreasonable to expect any already operating premises to have all infrastructure and/or equipment fully compliant without the need for maintenance. Where the FBO can demonstrate that infrastructure and/or equipment deficiencies have been identified and scheduled for repair in a way that manages any potential risk to public health, dependent on the nature and extent of the deficiency (i.e. minor / operational wear and tear), approval or conditional approval may be recommended.

3. Registered establishments taking advantage of the exemption criteria (refer to *Exemptions from Approval* section) and applying to undertake activities that are approved by the Agency, may be recommended for full approval following the initial approval visit. This can only be the case where the establishment and FBO controls have been observed in operation and complies with all the relevant requirements of food law (infrastructure, equipment and operational requirements) and any other relevant legislation as required for the type of approval. Note - The FBO will not be able to undertake activities, that are approved by the FSA (in this case working outside of the exemption criteria), until approval or conditional approval is granted.

Wholesale markets

4. Wholesale markets are defined in Regulation 853/2004 Annex I as food businesses that include several separate units which share common installations and sections (such as access corridors, loading bays, changing rooms, toilet facilities etc) where foodstuffs are sold to food business operators.

5. The common parts of wholesale meat markets must be approved as one establishment while individual stalls under the control of separate food business operators must be approved in their own right and receive an approval number consisting of the approval number for the common parts and a secondary number that is stall-specific.

6. Responsibility for complying with the Hygiene Regulations rests with the landlord of the market for the general areas within the market and with the individual food business operators for the unit(s) that they operate. However, FBOs for individually approved units have a duty to ensure that the common area requirements, providing the pre-requisites for hygienic operation such as waste disposal and pest control, are in place.

Multiple FBOs operating from one establishment

07. Where more than one FBO wishes to use a single premise to operate separate food businesses at different times, for example FBO A operates 09:00-17:00 and FBO B operates 17:00-09:00, approval may still be permitted but these situations will be assessed on a case by case basis.

08. The FBO/s for the individual businesses requiring approval using one premise will need to demonstrate how they plan to manage any food safety risks adequately. When undertaking the assessment the FSA must be satisfied that infrastructure, equipment and the FBO controls are acceptable before approvals can be granted. The arrangements regarding the operating pattern and joint use of the premises will be included in the approval document as a precondition to the approval.

09. Where the arrangements are satisfactory, approval or conditional approval will be granted to each FBO individually with each FBO receiving their own approval number. Refer to Allocation of approval number section.

10. When carrying out official controls, if the FSA needs to take enforcement action, for example due to non-hygienic operations or equipment deficiencies, this may be taken against both parties. As the terms of the joint use of the establishment are a precondition to the individual approval enforcement action must be taken against both parties regardless of which party caused the problem in the first place.

11. In the event that an FBO requiring approval to operate an establishment can only fully meet the requirements of the regulations by sharing certain facilities with a neighbouring FBO, approval may still be possible. These situations will be treated on a case by case basis but examples would include sharing facilities such as changing rooms, toilets, loading bays and chillers.

12. The FBO requiring approval using shared facilities will need to demonstrate how food safety risks are managed. When undertaking the assessment, the FSA must be satisfied that infrastructure, equipment and the FBO controls are acceptable before approval can be granted. Shared facilities will be identified in the approval document and marked on the site plan.

13. An example site plan identifying the shared facilities:

14. Where the arrangements are satisfactory, approval or conditional approval will be granted on the basis that the facilities being shared remain available and the requirements of the regulations continue to be fulfilled.

15. If at a point in the future the sharing of facilities is no-longer possible, the approval will be reviewed. Also refer to Review of meat establishments approval with the view to withdraw or suspend section.

16. When carrying out official controls, if the CA needs to take enforcement action, for example due to non-hygienic operations or equipment deficiencies, this will be taken against the party responsible for ensuring compliance. If both parties are responsible, enforcement may be taken against both.

Note - The facilities which are to be shared will form part of the approved establishment but they may be shared with a registered establishment. If enforcement action is required on the shared facilities this will be undertaken by the FSA if the operator responsible for the non-compliance is carrying out operations in relation to a slaughterhouse, a cutting plant or a game handling establishment, or by the LA in other cases where so empowered and by agreement. 73. Where the facilities in a slaughterhouse are only suitable for a particular age, size or type of animal, conditions may be imposed by the CA on the approval to control actual or potential risk to public health or animal welfare. Any such conditions will be stated to the approval documentation.

**Mobile Slaughterhouses**

74. When considering applications from FBOs seeking to operate a mobile slaughterhouse the FSA may consider permitting the use of shared facilities. The mobile slaughter unit may utilise facilities such as toilets, changing rooms and chillers with an approved or registered food business. However, these shared facilities will still be required to meet the necessary hygiene requirements for an approved slaughterhouse. As such, all mobile slaughterhouses will be required to comply with the same hygiene requirements as any static slaughterhouse.

**Granting or refusing approval**

75. Following an approval visit a veterinary official makes an assessment of the compliance with the approval requirements for the establishment and FBO controls. The results of this assessment will be formally confirmed by means of a recommendation to a senior civil servant.

76. In England and Wales a senior civil servant is responsible for decisions on whether or not to grant approval or conditional approval of a food business including any subsequent additional activities at an existing approved establishment. In NI the authorised official is the Head of Operations.

77. Approval assessment decisions must be notified to the FBO in writing in the form of an approval document which must include the following details: a. establishment for which approval is granted; b. identity of the FBO (refer to Application for approval section); c. activities for which approval or conditional approval is granted or refused; and d. in the case of conditional approvals, examples of any deficiencies (but not an exhaustive list) regarding the establishment &/or FBO controls.

78. In the case of Wholesale markets separate approval documents must be issued for the market as a whole and for individual units within the market, which are approved establishments in their own right.

79. In the event that a decision to refuse to grant approval is made, the FBO must be given notice of the decision, the reason why the decision was made and a list of deficiencies that were noted at the time of the visit including the requirements of the legislation in relation to hygiene, structure, HACCP or other elements relevant to the type of approval being sought and show how the FBO has failed to satisfy those requirements. The FBO has the right to appeal as per the following requirements:

80. The Official Feed and Food Controls Regulations provide that, if approval is refused, the operator has one month\* to appeal to a Magistrates’ Court (in England and Wales) or Court of Summary Jurisdiction (in Northern Ireland).

81. The time limit for lodging an appeal is one month from the date on which notice of the decision is served on the relevant person.

82. For matters under litigation, which is the case for establishments that have lodged an appeal, any communication relating to the appeal with either the FBO or their legal representatives must be directed to the point of contact in FSA Legal Services.

83. The Official Feed and Food Controls (Amendment) Regulations 2011 which came into effect on 1 April 2011 has removed the FBO’s right to continue operate under appeal. Therefore, the FBO will be required to cease operations requiring approval once the notice has been deemed to have been served.

84. Where the FBO lodges an appeal and the Magistrates’ Court, or Court of Summary Jurisdiction overturns the CA’s decision the CA must grant approval or conditional approval, in accordance with the courts’ decision. * - calendar month

85. From the date on which notice of the decision to refuse approval is served on the relevant person the establishment must cease approvable activities regardless of whether an appeal is lodged. Approval number / identification mark

Allocation of approval number

81. On granting approval or conditional approval the FSA will give each approved establishment an approval number. For wholesale markets, secondary numbers indicating units or groups of units may be added to the approval number. The approval number should be unique to the establishment/wholesale market and FBO during the period they are approved.

82. The following numbering system for regional variations in allocating approval numbers, to establishments approved by the FSA/FSS, will apply: a. England 1000-1099, 2000-6999 & 8000-8999 b. Scotland 1100-1999 c. Wales 7000-7999 d. Northern Ireland 9000-9999

83. In the case of individual units at wholesale markets, the approval number will consist of the approval number for the common parts and a secondary number that is stall-specific. The secondary number allocation is applied to help overcome problems with enforcement, traceability and differing standards of compliance between the different FBOs operating within the wholesale market.

84. Article 5 of Regulation 853/2004 requires that products of animal origin handled in establishments subject to approval are not placed on the market unless they have an identification mark (ID) or health mark.

85. Annex II, Section I B of Regulation 853/2004 requires that the mark must indicate the approval number of the establishment. The requirements for the form of the ID mark are as follows:

| Identification mark | |---------------------| | • The mark must be legible and indelible, and the characters easily decipherable. **It must be clearly displayed for the competent authorities.** | | • The mark must indicate the name of the country in which the establishment is located – it may be written out in full (United Kingdom) or a two-letter code used (GB or UK for Great Britain, and United Kingdom Northern Ireland or UK NI for Northern Ireland). | | • The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food. |

86. Where an establishment premise has been re-assessed for approval due to a change of FBO and approval is granted, generally a new approval number should be given. However, to have regard to issues of risk, cost and proportionality, a business may be able to retain its approval number where, other than for the change of FBO, the business is to continue to operate from the same premises and in essentially the same way, i.e. the type of food production by the business and the food safety control arrangements of the business will remain essentially the same. Also refer to Change of FBO section.

87. If the FBO moves to a new premise the CA may allow the FBO to retain the same approval number which was provided to them for the establishment which they are vacating. This will be subject to remaining with the same CA and the same country. The FBO will also still be required to submit a new application and be granted approval prior to operations commencing in the new location. In order to ensure that the approval number remains unique the previous approval will need to be surrendered by the FBO prior to it being granted for the approval at the new address.

88. In addition to the above, re-allocation of an approval number would only be permissible where the FBO of the business remains the same, and the activities remain substantially the same, when the establishment moves to a new location.

89. Where an establishment is approved in England or Wales by the LA and the FBO is subsequently granted an approval by the FSA, due to the establishment becoming co-located, the FSA will issue a new approval number to the establishment as a whole. In order not to penalise FBOs in this situation, upon request, a reasonable period of time (but typically not exceeding the conditional approval period) will be given for the business to use up old packaging. The request will be dealt with on a case by case basis in conjunction with the LA.

90. With regard to traceability Regulation 178/2002 Article 18(1) states “The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.” In the event that traceability is believed to be compromised due to fraudulent use of an identification mark (ID) or health mark the CA may issue a new approval number to the establishment. The original approval number will be removed from the official published lists, refer to List of approved establishments in the UK section, with the new number taking effect from a specified date.

List of approved establishments in the UK

90. The FSA maintains an up-to-date list of approved establishments and make it available to the public. The list of establishments will be updated by the FSA on a monthly basis.

91. The single published masterlist of approved food establishments in the UK is available from the FSA website14.

______________________________________________________________________

14 Masterlist of approved food establishments in the UK Review of meat establishments approval with the view to withdraw or suspend

92. Where non-compliances have been established the CA should take ‘appropriate measures to ensure the operator concerned remedies the non-compliance and prevents further occurrences of such non-compliance. When deciding what measures to take, the competent authorities shall take account of the nature of that non-compliance and the operator’s past record with regard to compliance’ Article 138 (1)(b) of Regulation 2017/625

93. Article 138(2) then goes onto state, ‘When acting in accordance with paragraph 1 of this Article, competent authorities shall take any measure they deem appropriate to ensure compliance with the rules referred to in Article 1(2), including, but not limited, to the following -

‘order the suspension or withdrawal of the registration or approval of the establishment, plant, holding or means of transport concerned, of the authorisation of a transporter or of the certificate of competence of the driver’

94. Where the evidence suggests that there is a serious risk in the form of major(^{15}) or critical(^{16})non-compliances the FSA will request guarantees over future production from the FBO. The guarantees should be a clear undertaking of action by an FBO to remedy the non-compliances which have been communicated to the FBO. There must be clear evidence of the intended action, the timescale for implementation and the expected outcome.

95. In the case of a wholesale market, Article 138 (EU) No 2017/625 allows the withdrawal or suspension of an approval in respect of certain units or groups within the market. In the event that the common parts of a wholesale market have the approval withdrawn or suspended, the individually approved units are not able to operate as the approval of the common parts facilities is a precondition to their approval. Where the units are able to become self-sufficient in their own right separate approval as individual establishments can be sought.

96. Referrals for review may be identified as a result of either performance monitoring when carrying out official controls (compliance and enforcement) or as a result of local intelligence.

97. Where a food business is referred for review of approval by those responsible for carrying out official controls and enforcement at the establishment or through local intelligence a preliminary review of the evidence will be undertaken by a veterinary official.

98. Where the preliminary evidence suggests a serious risk, the FSA will write to the FBO detailing the evidence indicating the non-compliances and provide the FBO with a timescale to provide adequate guarantees over future production and the resolution of

(^{15}) Major non-compliance - Likely to compromise public health (including food safety) or animal health or welfare or may lead to the production and handling of unsafe or unsuitable food if no remedial action is taken. When viewed collectively a number of related major non compliances may represent a critical non-compliance.

(^{16}) Critical non-compliance - Contravention poses an imminent and serious risk to public health (including food safety) or animal health and welfare these. During this period the FSA’s audit cycle of the food business will be suspended.

099. Where the preliminary evidence from a source other than an audit report suggests a serious risk the FVL may choose to conduct an unannounced inspection. If evidence indicates major/critical non-compliances these will be communicated to the FBO and guarantees requested as above.

100. Upon response from the FBO the FSA will conduct an unannounced inspection of the establishment when production is taking place and consider the adequacy of the guarantees provided by the FBO.

101. A recommendation will then be submitted by the veterinary official conducting the unannounced inspection to a SCS decision maker.

a) Where the FBOs guarantees regarding future production are not accepted as adequate the approval will be withdrawn

b) Where the CA does accept that the FBOs guarantees mean the non-compliances will be permanently resolved approval will continue. The next FSA audit will be arranged within three months.

c) Where the CA accepts that the guarantees mean the non-compliances will be permanently resolved within a reasonable time the approval will be suspended for that period of time.

102. Suspension of approval will be lifted once the non-compliances are permanently resolved. If this has not been undertaken within a reasonable time the approval will be withdrawn.

103. Where the FBO’s suspension has been lifted and the FBO returns to full operation such approval will remain under review when carrying out official controls and if the previously identified non-compliances recur the CA shall initiate procedures to withdraw approval.

104. The FBO has the right to appeal the decision to withdraw or suspend the approval as per the following requirements:

105. The Official Feed and Food Controls Regulations provide that, if approval is withdrawn or suspended, the operator has one month\* to appeal to a Magistrates’ Court (in England and Wales) or Court of Summary Jurisdiction (in Northern Ireland).

106. The time limit for lodging an appeal is one month from the date on which notice of the decision is served on the relevant person.

107. For matters under litigation, which is the case for establishments that have lodged an appeal, any communication relating to the appeal with either the FBO or their legal representatives must be directed to the point of contact in FSA Legal Services.

108. The Official Feed and Food Controls (Amendment) Regulations 2011 which came into effect on 1 April 2011 has removed the FBO’s right to continue operate under appeal. Therefore, the FBO will be required to cease operations requiring approval once the notice has been deemed to have been served.

109. Where the FBO lodges an appeal and the Magistrates’ Court, or Court of Summary Jurisdiction overturns the CA’s decision the CA must reinstate the approval or lift the approval suspension, in accordance with the courts’ decision.

- - calendar month

105. From the date on which notice of the decision to withdraw or suspend the approval is served on the relevant person the establishment must cease approvable activities regardless of whether an appeal is lodged.

Changes to an approval

General requirements

106. Article 6(2) of Regulation 852/2004 states the FBO is to “ensure that the competent authority always has up-to-date information on establishments, including by notifying, any significant change in activities and any closure of an existing establishment”. Not complying with this requirement is an offence under the Food Hygiene Regulations.

107. Where the FBO notifies the CA of such changes, consideration needs to be given as to whether a visit should be made to inspect the alterations and whether amended approval documentation is required. The amendment will depend on the extent of the changes, as follows: a. additional activities b. changes to acknowledged curtilage / internal restructuring c. change of FBO d. change of name e. closure of an approved establishment f. surrender of approval g. transfer of Official Controls to LA

Additional activities

108. The FBO of a fully approved establishment wishing to undertake (an) additional activities requiring approval (as detailed in Type of establishments section), must apply to the FSA for approval before carrying out the additional activity.

109. The usual approval procedures will be applied when assessing the additional activities for approval.

110. If a fully approved establishment’s most recent audit has the outcome ‘Improvement Necessary’ or ‘Urgent Improvement Necessary’ the FSA will not consider any applications for further activities or species until such time as the FBO has demonstrated sufficient improvement to exit the Improvement Necessary or Urgent Improvement Necessary status during a subsequent audit.

111. Professional judgement may be used, in the case of approving additional activities, to grant full approval in the first instance. This is only when the FSA reaches a point where they are satisfied with infrastructure, equipment and the FBO controls. Examples include adding an approval (this is not an exhaustive list): a. to slaughter goats at an existing sheep approved slaughterhouse b. to cut an additional meat type at an approved cutting plant already approved to cut two or more types of meat c. for a minced meat establishment to an already approved meat preparations establishment d. for the cold storage of meat e. for the re-wrapping and/or re-packaging of meat

Change to approved curtilage/restructuring

112. Significant curtilage changes and/or restructuring within the approved curtilage will necessitate the FBO providing revised plans indicating the changes.

113. Once acknowledged by the FSA, curtilage changes or restructuring should not require further or additional approval. It is the FBO’s responsibility to make sure that all such changes meet the respective requirements of the Regulations.

Change of FBO

114. The approval of an “establishment” applies to both the premises and the business operating at the premises. If an approved establishment changes FBO the food business will have to be assessed and granted a new approval under the name of the new FBO.

115. On change of FBO an establishment can continue to operate under the existing approval for a short period of time, but not exceeding a maximum of 25 working days after the change of FBO, until an approval assessment is carried out by the CA.

116. This provision is on condition that: a. the new FBO submits an application for a new approval that is received by the FSA within one calendar week of the change of FBO; and b. in order to safeguard public health, the new FBO must not change the operation at the premises in any significant way until a new approval is given, e.g. the new FBO must not change the type of animals slaughtered, nature of products produced / handled, and the HACCP based controls that have been subject to FSA audit.

117. The approval assessment will be undertaken as soon as possible and in all cases within 20 working days of receiving an approval application from the new FBO.

118. The FSA is prepared, on request by the FBO to carry out a pre change of FBO advisory visit, refer to Advisory visits section. However, any views given at such a visit will in no way provide a guarantee as to the future approval status of the business.

119. The different situations where a change in FBO, between different business entities, requires a new approval or where the approval can be retained are detailed in Annex F.

120. Article 6(2) of Regulation 852/2004 requires the FBO to inform the CA when there is a change of FBO. This will be by means of an application form as detailed in Application for approval section that includes the type of business entity, name of officers and relevant address/es of the FBO wishing to apply for approval. The FBO is then obliged to keep the FSA informed about significant changes to those details.

121. Once received by the FSA the application will be assessed in the same way as a new establishment and if approval is granted may be subject to a new approval number. Also refer to Allocation of approval number section.

122. Where the FSA becomes aware of a change of FBO at an establishment and the new FBO has failed to notify the change, the FSA will inform the FBO that the food business is no longer approved and must not undertake activities that require approval until a new approval has been issued. The FSA will also inform the relevant LA/DC of this so that the LA/DC can take appropriate enforcement action.

123. In the case of wholesale markets the following principles apply: a. The market overall approval (common parts) will be treated in the same way as an individual establishment FBO change but the individual units within the market do not need to be individually re-approved and can transfer over under the new market (common parts) approval. b. In the event that the common parts of a wholesale market are not granted approval, the individually approved units are not able to operate as the approval of the common parts facilities is a precondition to their approval. Where the units are able to become self-sufficient in their own right separate approval as an individual establishment can be sought. c. If an individual unit of a wholesale market changes FBO, this will be treated in the same way as an individual establishment FBO change.

Change of name

124. The approval document includes the details of the establishment and the identity of the FBO. Where there is a change of name in either of these areas, the approval document must reflect this.

Note – This is not to be confused with a change of FBO, which would warrant a re-assessment for approval. Refer to Change of FBO section.

125. The change of name does not affect any existing matters arising in relation to the establishment, which may be the subject of separate inspection or enforcement activity. FBO moving to different premises
126. If an approved food business relocates to a different address the FBO will need to apply for a new approval at this new address. The approval procedures will be applied when assessing the food business at the new address for approval.

Closure of an approved establishment 127. Where an establishment has a break in operation or closure the FBO is obliged to keep the CA informed. These breaks are categorised for operational purposes as follows:

Seasonal closure

1. An establishment may operate to a seasonal pattern with routine breaks in operation. Notification of this pattern must be provided by the FBO as part of the application process by identifying the months when the FBO intends to operate the establishment. The FBO is then obliged to keep the FSA informed about any significant changes to those details including any establishment moving to or from a seasonal pattern. When an FBO intends to re-commence operation the FSA needs to be notified at least two weeks before operations are intended to re-commence.

Temporary closure 2. When an FBO needs to temporarily halt operations due to renovation / development work at an establishment or due to a temporary downturn in trade the FBO is obliged to keep the FSA informed about these significant changes to the operational pattern. In these cases the FBO must notify the FSA at least two weeks before operations re-commence. Also refer to Change to approved curtilage/restructuring section.

Long-term closure 3. When an FBO stops operations with no immediate intention to recommence for at least six months or longer the closure is classed as long-term. The FBO is obliged to keep the FSA informed about this significant change to the operational pattern and must notify the FSA at least two weeks before operations re-commence.

Note – Temporary or long-term closures should not be confused with seasonal closures. Seasonal closures are pre-notified routine breaks in operation to a seasonal pattern.

128. During non-operational periods official controls undertaken by the FSA will be partially suspended, with the exception of ad hoc controls until operations re-commence.

129. In the case of audits of FBO procedures, undertaken by the CA, where the next scheduled audit falls within the closed period the audit will be undertaken within two months of operations re-commencing or sooner if needed.

130. Following a period of closure the FBO must notify the FSA before operations recommence. Keeping the FSA informed of significant changes is a regulatory requirement which allows the FSA to ensure it has up to date information. This notification allows the FSA to plan a visit to the premises to check the establishment continues to meet all structural and equipment requirements and other relevant requirements of food law, including the existence of a food safety management system based on HACCP principles.

131. The FBOs food safety management system must be available at the visit but as the establishment will not be operational, it will not be possible to assess how effectively this works in practice. The effectiveness of the FBO’s food safety management system will therefore be assessed at the first scheduled audit visit undertaken by the CA.

132. If there are major or critical non-compliances which indicate the establishment is a serious risk to public health or animal welfare appropriate enforcement action should be taken and the establishment could be subject to a formal review of approval. Also refer to Review of Meat Establishments Approval with the view to Withdraw or Suspend section.

133. Where the FSA becomes aware of an establishment that has re-commenced without first notifying the FSA appropriate enforcement action will be taken in regard to their failure to keep the FSA informed of significant changes.

134. If an establishment ceases to operate as food business the approval granted to it will no longer have effect. The FSA will monitor establishments which have ceased operating and not informed the FSA of their future plans. If the FBO does not confirm the surrender of their approval in writing within six months of the establishment ceasing operations then the FSA will write to the FBO to confirm their approval no longer has effect and the establishment will be removed from the published list of approved meat establishments

**Surrender of approval**

135. Where the FBO, of an establishment under their control, holding an approval, granted by the FSA, wishes to surrender that approval, the FBO is required to provide formal notice.

136. Once acknowledged by the FSA, the approval will cease to exist and the use of the approval number will also come to an end. The establishment will be removed from the official list of approved food establishments.

137. It would be an offence to resume activities subject to Regulation 852/2004 or Regulation 853/2004 at the establishment, before the FBO is granted approval or conditional approval or registered as appropriate by the relevant CA.

138. Where health marking carcasses at Slaughterhouses and/or Game Handling Establishments is carried out, health marking equipment will be retrieved. In establishments where ID marks are applied, following surrender, the FBO should be advised that it would be an offence to apply the ID Mark on any surplus labels or packaging.

139. Establishments undertaking activities that require an authorisation (e.g. a cutting plant removing SRM vertebral column from bovine carcases) which is based on the establishment holding an approval, the authorisation will automatically be revoked with the removal of the approval.

Transfer of Official Controls to LA

140. As detailed in Establishments requiring approval section, the FSA is the CA responsible for the approval of meat establishments and associated activities when co-located with an approved Slaughterhouse, Cutting Plant or Game Handling Establishment.

141. Where and FBO approved by the FSA, wishes to surrender the Slaughterhouse, Cutting Plant and/or Game Handling Establishment elements of their approval but wishes to retain stand-alone activities, this establishment, and the approval requirement, will be transferred to the LA or DC. In these circumstances the FSA will notify the relevant LA/DC accordingly. As the FSA had already approved the standalone activity, the LA/DC may not have to undertake a separate re-approval. This is provided that it is satisfied that the establishment can continue to meet all the requirements of the Regulations, and that the establishment’s food safety management system is adequate to cover the stand-alone activity.

142. In the case of FBOs deciding to limit their activities to meet the exemption criteria and surrendering the approval granted by the FSA, the establishment will remain subject to the Regulation 852/2004 and must therefore register with the LA as a Food Business prior to surrendering their approval. On surrender of the approval the establishment will be removed from the official list of approved food establishments.

## Annex A - Type of Establishments that require approval by FSA

| Establishments: | Activities / Operation for which establishment may be approved: | |----------------|---------------------------------------------------------------| | Slaughterhouse (Red Meat) | **Slaughter and/or Dressing of Domestic Ungulates:** | | | • Cattle (Bovine) | | | • Calves (Bovine) | | | • Bison | | | • Water buffalo | | | • Sheep (Ovine) | | | • Goats (Caprine) | | | • Pigs (Porcine) | | | • Domestic Soliped / Equidae (horses) | | | **Slaughter and/or Dressing of Farmed Game:** | | | • Farmed land mammals (other than domestic ungulates) | | | • Farmed Deer | | | • Farmed Wild Boar | | | • Ratites (Ostrich, rhea & emu) | | Slaughterhouse (White Meat) | **Slaughter and/or Dressing of Farmed Birds & Lagomorphs:** | | | • Domestic Fowls (Chickens, hens & broilers) | | | • Turkey | | | • Duck | | | • Geese | | | • Guinea fowl | | | • Quail | | | • Pigeon | | | • Ratites (Ostrich, rhea & emu) | | | • Lagomorphs (rabbits, hares and rodents) | | Game Handling establishment | **Dressing & cutting of:** | | | • Large wild game (e.g. wild deer & feral wild boar) | | | • Small wild game in-feather (e.g. pheasants, pigeons & grouse) | | | • Small wild game in-fur (e.g. rabbits, hares & rodents) | | Cutting Plant (Refer to Slaughterhouses and game handling establishment for definitions of species groups) | **Cutting of meat from:** | | | • Domestic ungulates | | | • Farmed birds & lagomorphs | | | • Large wild game | | | • Small wild game | | | • Farmed game | | Authorised On Farm Slaughter facilities | **Slaughter at the place of origin of:** | | | • Domestic Fowls (Chickens, hens & broilers) | | | • Turkey | | | • Duck | | | • Geese | | | • Guinea fowl | | | • Quail | | Establishments: | Activities / Operation for which establishment may be approved: | |----------------|---------------------------------------------------------------| | | • Pigeon | | | • Ratites (Ostrich, rhea & emu) | | | • Farmed Deer | | | • Farmed Wild Boar | | | • Bison | | Minced meat establishment\* | • Production of minced meat | | Meat preparations establishment\* | • Production of meat preparations | | Mechanically separated meat establishment\* | • Production of mechanically separated meat | | Processing Plant\* | **Processing of:** | | | • Meat products *(to be cooked before eating)* | | | • Ready to eat meat products | | | • Rendered animal fats and greaves | | | • Treated stomach, bladders, intestines | | | • Gelatine | | | • Collagen | | | • Raw milk | | | • Dairy products | | | • Egg products | | | • Fishery products | | | • Frogs’ legs & Snails | | Factory vessel\* | • Processing of fishery products (on board) | | Freezing vessel\* | • Freezing of fishery products (on board) | | Fresh fishery products plant\* | • Handling of unprocessed fishery products | | Auction hall\* | • Storing and displaying of fishery products | | Authorised Collection centre\* | • Collection of Raw milk | | Dispatch centre\* | • Reception, conditioning, wrapping and packing of Live bivalve molluscs | | Purification centre\* | • Purification of Live bivalve molluscs | | Packing centre\* | • Packing of eggs | | Liquid egg plant\* | • Handling of unprocessed egg contents | | Cold Store\* | • Storage of POAO (fresh or processed) | | Re-wrapping/re-packaging establishments\* | • Re-wrapping and/or repackaging of POAO (fresh or processed) | | Wholesale market | • Shared common installations and sections where foodstuffs are sold |

- Standalone establishments of these types of operation are approved by Food Authorities i.e. Local Authorities or District Councils. The exception to this are egg packing centres in Northern Ireland and some dairy establishments in Northern Ireland. Annex B - Exemption Criteria

A – Retail establishments

The exemption is for retail establishments that supply food of animal origin to the final consumer, or supply other retail establishments (including caterers) on a ‘marginal, localised and restricted basis (853/2004 Article 1 Scope point 5).

Regulation 853/2004 interprets marginal as a small part of the establishment's business, but subsequent guidance provides that it may also be interpreted as a small amount of food of animal origin in absolute terms. Following consultation, the UK is interpreting the terms marginal, localised and restricted in relation to meat as follows:

- **Marginal**: supply of food of animal origin: (i) up to a quarter of the business in terms of food; or (ii) in relation to: fresh or processed meat, (but not wild game meat) up to 2 tonnes a week, subject to the establishment having a genuine retail outlet supplying the final consumer with part of its production of meat;

  and

- **Localised**: supply of food of animal origin within the supplying establishment’s own county plus the greater of either the neighbouring county or counties or 50 km/30 miles from the boundary of the supplying establishment’s county;

  and

- **Restricted**: supply of food of animal origin is limited to certain types of products or establishments. In the meat sector, the restrictions are in relation to the amounts of meat supplied and the requirement for a ‘genuine’ retail outlet (see ‘marginal’ above).

**Notes**: Up to a quarter of the business in terms of food “should be calculated by measuring the amount (either by weight or volume) of food of animal origin supplied to other food business establishments (including caterers) against the entire supply in terms of food (this includes food of any type, e.g. drink, biscuits etc).

2 tonnes could be averaged over any 12 month period.

Both the above criteria must not be used simultaneously at an establishment. It is either the 25% or the 2 tonne rule (for establishments that only handle meat).

Supply to a final consumer can include mail order and internet sales. Retail establishments attached to approved establishments under veterinary control do not require approval.

**Multiple premises constituting a single food business establishment in England and Wales**

Where establishments in England and Wales supply food to one or more retail units closely linked under the same ownership there may be circumstances where the CA may wish to consider the separate sites as part of a wider establishment and therefore a ‘single establishment’ for which a single registration will be required. This flexibility may only be applied where the main focus of the establishment’s activities is that of a retail business, i.e. when supply of food is direct to the final consumer. CA’s will consider such businesses on a case by case basis to ensure that all three of the following criteria are satisfied:

1. The operation is under a single ‘controlling mind’, i.e. there is one person who is responsible for the implementation of HACCP-based procedures; and
2. One set of ‘HACCP-based procedures’ covers all stages and units of the operation within the wider establishment; and
3. All the activities undertaken at the various units within the ‘wider’ establishment are within close enough proximity that it can be reasonably expected that the single controlling mind can effectively manage the food safety management controls at all sites.

Where all three criteria are met, but the main activity of the establishment is the supply of POAO to other businesses, then approval is required (unless it meets the permitted exemptions in Article 1 of 853/2004). Competent Authorities should refer to and consider the guidance document on the implementation of certain provisions of Regulation 853/2004 on the hygiene of food of animal origin.

B – Poultry slaughter and cutting on farm

There is an exemption for producers supplying small quantities of meat from poultry and lagomorphs slaughtered, on the farm where they are grown, directly to the final consumer and to local retail establishments directly supplying the final consumer (853/2004 Article 1 point 3d amended by Regulation 2076/2005 Article 3).

Producers must be registered and comply with Regulation 852/2004 and the labelling and record keeping requirements of Schedule 5 of the Food Safety and Hygiene Regulations (England) 2013 or equivalent legislation in Wales and Northern Ireland. Following consultation, the UK is interpreting the terms small and local as follows:

- ‘Small’ supply is interpreted as (i) under 10,000 birds or lagomorphs; or (ii) producers annually slaughtering over 10,000 birds or lagomorphs who are members of an appropriate assurance scheme and who either (a) dry pluck by hand or (b) slaughter for 40 days per year or less;

and

- ‘Local’ supply is interpreted as being the same as ‘localised’ – see ‘A’ above; additionally anywhere within the UK in the two weeks preceding Christmas or Easter and for geese, Michaelmas (late September).

C – Slaughter for private domestic consumption – home slaughter of livestock

When slaughter of a livestock animal is carried out by its owner on their property for their own personal consumption or that of members of their immediate family living there and the meat is not placed on the market (whether free of charge or not), such activity is exempt from both Regs 852/2004 and 853/2004, although the Food Safety Act (or in NI the Food Safety Order) will apply. However, the TSE Regulations apply wherever a TSE susceptible animal (i.e cattle, sheep and goat) is slaughtered (including home slaughter). Animal Welfare Regulations also apply wherever livestock is slaughtered. It should be noted that home slaughter is likely to carry a greater human health risk than slaughter that takes place in approved premises.

D – Wild game There is an exemption for primary producers (individual hunters or shooting estates) supplying small quantities of wild game carcases in fur/feather directly to the final consumer and to local retail establishments directly supplying the final consumer (853/2004 Article 1 point 3c).

There is also an exemption for hunters and active members of a hunting party supplying small quantities of wild game meat directly to the final consumer and to local retailers directly supplying the final consumer. The meat must be prepared by an individual who has played an active part in the shoot, such as a beater, so the exemption is available to shooting estates. (853/2004 Article 1 point 3e). The amount of meat supplied to other establishments should be measured against the entire business in terms of food, whether retail or wholesale including food of any type, e.g. drinks, biscuits etc. If this does not exceed a quarter of the food business, the establishment is exempt from approval. Where there is supply of meat only, up to 25% of the meat may be wholesaled.

Note: In this part of the exemption the requirement for a retail element is not essential. Therefore, cash & carries are exempt if they fulfil the 25% criteria despite being completely wholesale.

Accept even a small amount of retail providing it is genuine and not merely an attempt to gain exemption (could include internet, mail order etc).

Don’t include meat, meat preparations or meat products that are bought in and not cut or processed on site.

Is all supply within the establishment’s county, plus the greater of, either the neighbouring county or counties or 30 miles/50kms from the boundary of the establishments’ county? Annex D - Approval process – Decision flow diagram

- **Key**-

  - ~ requirements met for approval / conditional approval to be granted.
  - ▲ - Deficiencies to be rectified before approval / conditional approval can be granted.
  - ▼ - Approvable activities not able to be observed, approval / conditional approval discontinued.
  - ▼ - Requirements not met for approval / conditional approval to be granted. Annex E - Review of approval - Decision flow chart

- **Approval will continue**

  - **NO**
  - Are there serious deficiencies or have there been repeated stoppages of production?
    - **YES**
    - Can adequate guarantees be given regarding future production?
      - **NO**
      - Approval will be withdrawn
      - **YES**
      - Do the guarantees mean that deficiencies will be permanently resolved immediately and that there will be no foreseeable future stoppages of production?
        - **NO**
        - Do the guarantees mean that deficiencies will be permanently resolved within a reasonable time and the situation will be such that, once the deficiencies have been resolved, there will be no foreseeable future stoppages of production?
          - **NO**
          - Approval will be suspended
          - **YES**

- **YES**

  - Approval will continue

### Annex F - Change of FBO

| Existing FBO (as per approval documentation) | Change of FBO (in each case assuming no other changes to the business) | Approval status | Comments | New approval required | |---------------------------------------------|---------------------------------------------------------------------|----------------|----------|-----------------------| | 1 Sole trader, Partnership or incorporated company (e.g. Ltd, PLC, etc) | Different sole trader, partnership or incorporated company takes over ownership | Expires | Discontinuation of operator/s | Yes | | 2 Sole trader or Partnership | Company incorporated (and registered), Sole trader or partner/s becomes Director/s | Expires | Creation of a Company so the company is responsible not the individual/s | Yes | | 3 Sole trader | Creation of a partnership where the sole trader is one of the partners | Retained | Continuation of operator | No | | 4 Partnership | Dissolved and one of the partners takes over sole ownership and becomes a sole trader | Retained | Continuation of operator | No | | 5 Partnership | New partner joins or a partner leaves (also refer to dissolved partnership) as long as there is a continuation of at least one partner | Retained | Continuation of operator/s | No | | 6 Incorporated company | Company goes into administration and is being run as a going concern by the administrators. | Retained | Continuation of operator/s | No | | 7 Incorporated company in administration | Company taken over from administrators by a different sole trader, partnership or incorporated company | Expires | Discontinuation of operator/s | Yes | | 8 Sole trader, Partnership or Incorporated company | Bankruptcy, insolvency or in liquidation (wound up / dissolved) | Expires | Discontinuation of operator/s, approval expires | N/A |

Other business types such as cooperatives, registered charities and other specialised types of organisation will be treated on a case by case basis to identify the change in natural person or legal person required to be compliant with food law within the food business under their control. Annex G - Relevant offences

This list is correct as of the date of this revision. Legislation may change at which point the offences listed may not be comprehensive. This table, therefore, is not intended as definitive.

Offences

The Food Safety (General Food Hygiene) Regulations 1995 The General Food Law Regulation 2004 The Food Hygiene (England/Wales/Northern Ireland/Scotland) Regulations 2006 The Food Safety and Hygiene (England) Regulations 2013 Food Safety Act 1990 (seizure/detention) The Food Safety (Northern Ireland) Order 1991 Welfare of Animals (Slaughter and Killing) Regulations 1995 Welfare of Animals at Time of Killing (England) Regulations 2015 Welfare of Animals at Time of Killing (Wales) Regulations 2014 Welfare of Animals at Time of Killing (Scotland) Regulations 2012 Tuberculosis (England) Order 2005/3446 Tuberculosis (England) Order 2014/2383 Tuberculosis (Wales) Order 2010/1379 Tuberculosis (Scotland) Order 2007/147 Tuberculosis in specified animals (Scotland) Order 2015/327

## Glossary

Definitions and abbreviations used in this document:

| Term | Definition | |------|------------| | **Animal by-products (ABP)** | Parts of animal which are not intended for human consumption | | **Audit** | A systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives | | **Carcase** | The body of an animal after slaughter and dressing | | **Cold store** | Cold Store is not defined in the Hygiene Regulations. For the purposes of approval the FSA considers a cold store to be a wholesale establishment, not forming an integral part of a Slaughterhouse, Cutting Plant or Game Handling Establishment, used for the storage under temperature controlled conditions of POAO intended for sale for human consumption | | **Collagen** | The protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of this Regulation | | **CA** | The competent authority for the organisation of official controls or any other authority to which that competence has been conferred; it shall also include, where appropriate, the corresponding authority of a third country | | **Composite products** | This is the term generally used for food containing both products of plant origin and processed products of animal origin as indicated in Article 1.2 of Regulation 853/2004 | | **Cutting plant** | An establishment used for boning and/or cutting up meat | | **Dairy products** | Processed products resulting from the processing of raw milk or from the further processing of such processed products | | **DAERA** | Department of Agriculture, Environment and Rural Affairs | | **DC** | District Council | | **Dispatch centre** | Any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption | | **Domestic ungulates** | Domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds | | **Edible co-products** | Parts of animals that are unsuitable for human consumption when they are produced at the slaughterhouse, but which can later be processed for use in human food, e.g. hides and skins processed into gelatine and collagen, sheep intestines processed into sausage casings, and stomach (omental) fat processed into lard. In order to be considered as an edible co-product, the product should not have been at any stage considered or handled as Animal By-product and must have been handled and stored in accordance with the Hygiene Regulations. Edible co-products must be handled in accordance with the food hygiene legislation at all stages of their production. At no point should they come into contact with or be categorised as animal by-product. If this happens they should immediately be removed from the human food chain and down-graded to animal by-product | | **Egg products** | Processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products | | **Establishment** (Also refer to definition of a “Premises”) | Any unit of a food business. An “establishment” does not simply mean “premises”, but is directly linked to the food business occupying the premises (establishment denotes both premises and the manner in which those premises are being used by the food business operator) | | **Factory vessel** | Any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing | | **Farmed game** | Farmed ratites and farmed land mammals other than Domestic ungulates | | **Final consumer** | The ultimate consumer of a foodstuff who will not use the food as part of any food business activity or operation | | **Food business** | Any undertaking whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food | | **Food business operator (FBO)** | The natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control | | **Food (or foodstuff)** | Any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans | | **Food law** | The laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals | | **Freezer vessel** | Any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging

**Fresh meat**\
Meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere

**FSA**\
Food Standards Agency (CA for food safety in England, Wales and Northern Ireland)

**FSS**\
Food Standards Scotland (as from 1 April 2015 FSS is the CA for food safety in Scotland)

**Game handling establishment**\
Any establishment in which game and game meat obtained after hunting are prepared for placing on the market

**Gelatine**\
Natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals

**Greaves**\
The protein containing residue of rendering, after partial separation of fat and water

**HACCP**\
Hazard Analysis and Critical Control Point (food safety management system)

**Hazard**\
a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect

**Health mark**\
A mark indicating that, when it was applied, official controls had been carried out

**Hygiene (in respect to food hygiene)**\
The measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use

**Identification mark (ID)**\
A mark indicating that a POAO has been produced in an approved establishment in accordance with legal requirements

**Inspection**\
The examination of establishments, animals and food, of their processing, of food business, of their management and productions systems, including finished product testing and feeding practices, and of their origin and destination of production inputs and outputs, in order to verify that all these items conform to legal requirements

**Lagomorphs**\
Rabbits, hares and (edible) rodents

**Large wild game**\
Wild land mammals living freely in the wild that do not fall within the definition of small wild game

**LBMs**\
Live bivalve molluscs. ‘Bivalve molluscs’ means filter-feeding lamellibranch molluscs

**Liquid egg**\
Unprocessed egg contents after removal of the shell

**Meat**\
Edible parts of an animal, including blood:

- Domestic ungulates: bovine, ovine, caprine & domestic solipeds;
- Poultry: farmed birds • Lagomorphs: rabbits, hares and rodents • Large wild game: wild land mammals • Small wild game: wild game birds and lagomorphs

Farmed game: farmed ratites and farmed land mammals

Meat preparations • Fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasoning or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus eliminate the characteristics of fresh meat

Meat products Processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat

Mechanically separated meat (or MSM) The product obtained by removing meat from flesh bearing bones after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle fibre structure

MIG Guide to food hygiene and other regulations for the UK meat industry (commonly known as the Meat Industry Guide)

Minced meat Boned meat that has been minced into fragments and contains less than 1% salt

Non-compliance Non-compliance with feed or food law, and with the rules for the protection of animal health and welfare

Offal Fresh meat other than that of the carcase, including viscera and blood

Official controls Any form of control that the CA performs for the verification of compliance with feed and food law, animal health and animal welfare rules

Packaging The placing of one or more wrapped foodstuffs in a second container, and the latter container itself

Packing centre An establishment where eggs are graded by quality and weight

Placing on the market The holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves

POAO Product of Animal Origin means: • Food of animal origin, including honey and blood; • Live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and

Other animals destined to be prepared with a view to being supplied live to the final consumer Poultry

- Farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites.

Premises

(Also refer to definition of an “establishment”)

Includes any place, any vehicle, stall or moveable structure and, for such purposes as may be specified in an order made by the Ministers, any ship or aircraft of a description so specified in Part 1 (3) of the Food Safety Act 1990 / the Food Safety (Northern Ireland) Order 1991

Primary production

The production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter, it also includes fishing and harvesting of wild products

Primary products

Products of primary production including products of the soil, of stock farming, hunting and fishing. Primary products include amongst other things:

- Products of plant origin: grains, fruits, vegetables, herbs etc
- Products of animal origin: eggs, raw milk, honey, fishery products, LBM

Products harvested from the wild either from plant or animal origin, e.g. mushrooms, berries, snails etc

Processed fishery products

- Processed products resulting from the processing of fishery products or from the further processing of such processed products

Processed products

Foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics

Processing plant

An establishment where POAO are either treated, processed (heating, smoking, curing etc) and wrapped or undergoes one or more of those handling activities

Purification centre

An establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption

Raw milk

Milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40 °C or undergone any treatment that has an equivalent effect

Ready-to-eat food

Food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing

Rendered animal fat

Fat derived from rendering meat, including bones, and intended for human consumption

Retail

The handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets

Risk

A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard

17 Food Safety Act 1990 / Food Safety (Northern Ireland) Order 1991 | Term | Definition | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Re-packaging establishment | An establishment which removes wrapped foodstuffs from a second container and re-packages them without removing the initial wrapping which is in direct contact with the product. | | Re-wrapping establishment | An establishment that unwraps the initial wrapping or initial container, which is in direct contact with the product and then re-wraps the products. | | Slaughterhouse | An establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption. | | Small wild game | Wild game birds and lagomorphs living freely in the wild. | | Stages of production, processing and distribution | Any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed. | | Traceability | The ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution. | | Treated stomachs, bladders and intestines | Stomachs, bladders and intestines that have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning. | | Unit | A single undivided entity or whole. | | Unprocessed products | Foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed. | | Verification | Checking, by examination and the consideration of objective evidence, whether specified requirements have been fulfilled. | | Viscera | The organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus and, in birds, the crop. | | Wholesale market | A food business that includes several separate units which share common installations and sections where foodstuffs are sold to food business operator. | | Wild game | Means: | | | - wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game; and | | | wild birds that are hunted for human consumption. | Wrapping

- The placing of a foodstuff in a wrapper or container in direct contact with the foodstuff concerned, and the wrapper or container itself. (Therefore re-wrapping means the replacement of initial wrapping or initial container, which is in direct contact with the product)